A Phase I, open-label trial to investigate pharmacokinetics, safetyand tolerability of TMC125 at steady-state in treatment-experiencedHIV-1 infected children.

Tibotec Pharmaceuticals Ltd0 sites40 target enrollmentStarted: July 7, 2006Last updated: April 24, 2012

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor
Enrollment: 40

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1. Boys and girls = 6 and = 17 years old.
•2. Subjects with documented HIV-1 infection.
•3. Subjects weighing = 20 kg and with weight < P90 according to the CDC growth charts
•4. Being able to swallow the TMC125 tablet(s).
•5. Subjects currently on a stable regimen of least 2 NRTIs and LPV/rtv with or without ENF (at approved pediatric doses) for at least 2 months who are not expected to change their regimen in the next 15 days and with a VL < 50 copies/mL on 2 consecutive determinations (last VL measurement in medical file + screening VL measurement, should be taken at least 1 month apart).
•6. Parents or legal representative and trial subjects (where appropriate, depending on age and local regulation) willing and able to give consent. Children will be informed about the trial, and asked to give positive assent
•7. Subjects can comply with the protocol requirements. Parents or legal representatives of the subjects will be instructed by the investigator to adequately supervise the subject’s protocol adherence.
•8. General medical condition, in the investigator’s opinion, does not interfere with the
•assessments and the completion of the trial.
•9. Sexually active boys, or girls who are sexually active and able to become pregnant, must either practice sexual abstinence during the trial or use a safe and effective birth control method such as a double barrier method of contraception (i.e., using a condom with either spermicidal cream/foam/gel or diaphragm or cervical cap) or hormone-based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap with spermicide or female condom with spermicide) during the trial. Hormonal birth control alone is not considered to be adequate.
•Note: Spermicides containing non-oxynol-9 should not be used as this can potentially
•increase the rate of HIV-1 transmission.
•10. Non-smoking or smoking no more than 10 cigarettes per day for at least 3 months prior to selection.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•1. Use of disallowed concomitant therapy
•2. History or current use of alcohol (more than 2 units per day), barbiturates, amphetamines, recreational or narcotic drugs, which in the investigator’s opinion would compromise the subject’s safety and/or compliance with the trial procedures.
•3. Life expectancy of less than 6 months according to the judgment of the investigator.
•4. Presence of any currently active AIDS defining illness (Catergory C conditions according to the CDC Classification System for HIV Infection 1993 or according to the 1994 revised CDC Classification System for HIV Infection in Children less than 13 years of age
•Note: An AIDS defining illness not clinically stabilized for at least 30 days will be
•considered as currently active.
•Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed in cases where the medication administered is not part of the disallowed medications 5. Any active clinically significant disease (e.g. TB, malignancies, cardiac dysfunction,
•pancreatitis, acute bacterial or viral infections) or findings during screening of medical
•history or physical examination that, in the investigator’s opinion, would compromise the subject’s safety or outcome of the trial.
•6. Subjects with history or at risk of bleeding disorders.
•7. Acute and/or chronic viral hepatitis including but not limited to A, B, or C (confirmed by hepatitis A antibody IgM, hepatitis B surface antigen, or hepatitis C virus antibody, respectively) at screening.
•8. Receipt of an investigational drug within 30 days prior to the trial drug administration.
•9. Previously demonstrated clinically significant allergy or hypersensitivity to TMC125 or any of the excipients of the investigational medication administered in this trial.
•10. Any history of significant ARV drug rash requiring permanent drug discontinuation or other clinically significant drug allergy, drug rash, eruptions or urticaria.
•11. Pregnancy or breastfeeding.
•12. Any grade 3 or grade 4 toxicity according to the Division of AIDS (DAIDS) grading scale
•Note: Retesting of abnormal screening values that lead to exclusion will be allowed only once using an unscheduled visit during the screening period (to reassess eligibility).
•13. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio [INR]> 1.5 or albumin < 30 g/L or bilirubin > 2.5 x ULN).
•14. A positive urine drug test at screening. Urine will be tested to check the current use of amphetamines, benzodiazepines, cocaine, cannabinoids, and opioids.
•15. Currently significant diarrhea, gastric stasis, or constipation that in the investigator’s opinion could influence drug absorption or bioavailability.
•16. Having developed rash, erythema, or urticaria while participating in Stage I of this trial.

Investigators

Sponsor

Tibotec Pharmaceuticals Ltd

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